MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) battery 1 not full charging 75 percent.There was no patient harm reported.

Event Description

It was reported that while the cardiosave intra-aortic balloon pump (iabp) was in the storage room, battery #2 was sitting at 75% charge and not charging while connected to ac power.Two days later, they found the same result, battery #2 was at 75%.There was no patient involvement.

Manufacturer Narrative

It was reported that cardiosave intra-aortic balloon pump (iabp) battery will not charge.The operator reported that battery #2 was sitting at 75% charge and not charging while connected to ac power (in the storage room, no patient).He found the same result two days later (battery #2 at 75%).The unit was brought to biomed and plugged in.A getinge field service engineer evaluated fse found that both batteries were fully charged.Fse ran the unit on ac power all day and the batteries never dropped below full charge.Fse left the unit on ac power for the weekend and the batteries never dropped.Fse could not duplicate the reported error.Fse found one instance of "tec#118 powrman sol wdt fail" from (b)(6) 23.Fse could not duplicate the error.Fse replaced the safety disk and tidal disk on expiry.Fse tested the drive solenoids and had no issues.Fse completed a full system test / pm protocol, all tests passed to factory specifications.Returned to the customer and released for clinical use.There was no patient involvement.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18518646
• MDR Text Key: 332934135
• Report Number: 2249723-2024-00181
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 05/14/2024
• Supplement Dates FDA Received: 05/13/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1